ZENEX Guide Mini Kit

GUDID 08800070233306

T-System All-in-One

Izenimplant Co., Ltd.

Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Primary Device ID08800070233306
NIH Device Record Keyc13ec53c-492c-49b8-b722-57cda020cc57
Commercial Distribution StatusIn Commercial Distribution
Brand NameZENEX Guide Mini Kit
Version Model NumberZENGMATKIT
Company DUNS694625347
Company NameIzenimplant Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numbertrue
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800070233306 [Primary]

FDA Product Code

NDPAccessories, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800070233306]

Moist Heat or Steam Sterilization


[08800070233306]

Moist Heat or Steam Sterilization


[08800070233306]

Moist Heat or Steam Sterilization


[08800070233306]

Moist Heat or Steam Sterilization


[08800070233306]

Moist Heat or Steam Sterilization


[08800070233306]

Moist Heat or Steam Sterilization


[08800070233306]

Moist Heat or Steam Sterilization


[08800070233306]

Moist Heat or Steam Sterilization


[08800070233306]

Moist Heat or Steam Sterilization


[08800070233306]

Moist Heat or Steam Sterilization


[08800070233306]

Moist Heat or Steam Sterilization


[08800070233306]

Moist Heat or Steam Sterilization


[08800070233306]

Moist Heat or Steam Sterilization


[08800070233306]

Moist Heat or Steam Sterilization


[08800070233306]

Moist Heat or Steam Sterilization


[08800070233306]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-10-02
Device Publish Date2023-09-22

On-Brand Devices [ZENEX Guide Mini Kit]

08800070231777R-System
08800070231760T-System
08800070231753I-System
08800070231708ZENGMKIT
08800070233306T-System All-in-One

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